The present invention relates generally to medical devices that may be used for cell delivery, and in certain embodiments to systems and methods by which the delivery passageways of such medical devices can be tested for their impact upon cells.
The field of cell therapy has been investigated for some time in an effort to provide improved medical treatments for patients across a broad variety of conditions or injuries. Despite some demonstrated promise in research, the clinical implementation of cell therapy has been slow. The identification of cell types and modes of administration that prove to be reliably beneficial to patients has been difficult, and the reasons for failure or only sporadic success in the clinical setting are not well known. Cells are known to be sensitive to both physical and chemical stimuli, but the identification of stimuli that may or may not benefit for detract from a proposed therapy has been limited.
In many proposed clinical applications, cells must be introduced noninvasively to the patient, and delivery devices are needed for these purposes. Little work or understanding has been reported, however, as to what specifications need be considered when developing or manufacturing delivery devices for cells in cell therapy. Critical needs thus exist in this area that take into account both the biologic sensitivities of the therapeutic agent—cell—and the complexities of medical delivery device design and manufacture. The present invention, in at least several of its aspects, is addressed to these needs.